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FDA authorizes at-home COVID-19 test kit

(Image from Unsplash)

The FDA announced that it issued emergency use authorization for Everlywell’s at-home sample collection kit for COVID-19 diagnostic testing.

Everlywell’s kit has authorization for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit can then be sent to specified laboratories for COVID-19 testing.

The FDA also authorized two COVID-19 diagnostic tests (under two separate EUAs) for use with samples collected using the Everlywell COVID-19 home collection kit. The administration is open to authorizing additional tests should data be submitted that demonstrates the accuracy of the test when used with Everlywell’s kit.

Using the Everlywell kit that contains nasal swabs, a sample is collected from inside the patient’s nose and used with a tube filled with saline to tran…

Medtech 100 roundup: Stocks dip slightly after strong start to month

Medtech stocks ticked down over the course of last week as the COVID-19 pandemic continues to bear economic ramifications.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 82.4 points at the end of last week (May 15). That total represents a -1.9% decline from the 83.98-point total at the same time a week prior (May 8).

The lowest point during the pandemic remains at 62.13 on March 23. Since then, medtech stocks have experienced 32.6% growth in total. However, they are still down -10.7% since the index’s pre-pandemic crash high point of 92.32 on Feb. 19.

Compared to the S&P 500 Index, which experienced a -2.2% increase from May 8 to May 15, the medtech index took a similarly small dip. The Dow Jones Index suffered even more with a -2.6% decline over the same period of time.

More often than not, recent earnings reports are revealing negative results in large part due to COVID-19. E…

Small study yields ‘really good news’ for COVID-19 vaccine odds

Alba Grifoni, a postdoctoral researcher in the Sette lab and study first co-author, tests the T cell response in blood samples collected from individuals who have recovered from COVID-19. (Image from the La Jolla Institute of Immunology)

Scientists at the La Jolla Institute for Immunology have documented a robust antiviral immune response to SARS-CoV-2 in a group of 20 adults who had recovered from COVID-19.

Their work, published in today’s online edition of Cell, show that the body’s immune system is able to recognize SARS-CoV-2 in many ways, dispelling fears that the virus may elude ongoing efforts to create an effective vaccine.

The collaboration between the labs of Alessandro Sette and Shane Crotty, both professors at the institute’s Center for Infectious Disease and Vaccine Research, offers some good news for vaccine developers and is providing the first cellular immunology data to help guide soc…

Medical device VCs give long-term pandemic perspectives

In Episode 10 of DeviceTalks Weekly, we talk with two successful starters of medtech companies about how they’re building and maintaining their medtech portfolios during this pandemic landscape.

Our guests this week are Dr. Justin Klein, managing partner of Vensana Capital, and Duke Rohlen, chair of Ajax Health. Together, Klein and Rohlen have created, backed and sold medtech companies that have generated billions.

Klein, formerly of New Enterprise Associates, now co-manages his own venture firm, Vensana Capital. He previously served on the board of directors of Cartiva (acquired), ChromaCode, CV Ingenuity (acquired), EPIX Therapeutics (acquired), FIRE1, GPB Scientific, Intact Vascular, Metavention, Personal Genome Diagnostics, PhaseBio Pharmaceuticals (IPO), Relievant Medsystems, Senseonics (IPO), Topera (acquired), Ulthera (acquired), Vertiflex (acquired), Vesper Medical and VytronUS (acquired).

Rohlen, who leads a holdings company backed by private eq…

Medtronic touts positive results for Melody TPV, Harmony TPV

Medtronic (NYSE:MDT) today announced the results of two successful clinical trials for its Melody transcatheter pulmonary valve (TPV) therapy.

The Fridley, Minn.-based medtech giant virtually presented its 10-year outcomes at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) scientific sessions. Melody demonstrated strong long-term hemodynamic and safety outcomes, while the investigational Harmony TPV pivotal trial met safety and efficacy endpoints for hemodynamic function at six months, according to a news release.

Melody TPV demonstrated consistent hemodynamics through 10 years with strong valve efficacy with 97% none/trace/mild pulmonary regurgitation. Annualized incidence of TPV-related endocarditis was 2% per patient-year, while freedom from major stent fracture came in at 84% at 10 years and freedom from reintervention was 61%.

That study included 150 implanted patients between age 7 and age 53, with a median age of 19 and …

How do medtech investors, CEOs manage portfolio companies going forward?

DeviceTalks Weekly

In Episode 10 of DeviceTalks Weekly, we talk with two successful starters of medtech companies about how they’re building and maintaining their medtech portfolios during this pandemic landscape.

Our guests this week are Dr. Justin Klein, managing partner of Vensana Capital, and Duke Rohlen, chair of Ajax Health. Together, Klein and Rohlen have created, backed and sold medtech companies that have generated billions.

Klein, formerly of New Enterprise Associates, now co-manages his own venture firm, Vensana Capital. He previously served on the board of directors of Cartiva (acquired), ChromaCode, CV Ingenuity (acquired), EPIX Therapeutics (acquired), FIRE1, GPB Scientific, Intact Vascular, Metavention, Personal Genome Diagnostics, PhaseBio Pharmaceuticals (IPO), Relievant Medsystems, Senseonics (IPO), Topera (acquired), Ulthera (acquired), Vertiflex (acquired), Vesper Medical and Vytro…

Could face masks light up to detect COVID-19?

Researchers at Harvard University have developed a face mask with a sensor to detect COVID-19, according to a BusinessInsider report.

Wyss Institute researcher James Collins and his group developed a rapid self-activating COVID-19 diagnostic face mask. It can be worn by patients or people at home who have symptoms of coronavirus to quickly signal the presence of the virus without the need for hands-on manipulation, according to Harvard University.

Collins and the researchers suggest that patients can be easily triaged for proper medical care while healthcare workers and patients nearby are protected by using the diagnostic wearable.

The mask is made using highly sensitive molecular sensors coupled to synthetic biology networks and shows an immediately visible or florescent color signal when CoV2 is detected. It is cell-free molecular machinery that is freeze-dried and integrated with synthetic material on the interior of the face mask.

Once expose…

Hologic granted second molecular COVID-19 test EUA

Hologic (NSDQ:HOLX) announced today that it received FDA emergency use authorization (EUA) for its Aptima SARS-CoV-2 assay for detecting COVID-19.

Marlborough, Mass.-based Hologic’s Aptima test runs on its fully automated Panther system that provides initial results in approximately three hours, processing more than 1,000 coronavirus tests in 24 hours.

Hologic said in a news release that it began distributing the new test and expects to produce an average of one million tests per week by combining its manufacturing capacity with what it touts as the world’s largest installed base of high-throughput molecular instruments.

Aspects of the Aptima assay project were conducted under a $13 million contract from the U.S. Dept. of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA).

Hologic intends to register the Aptima SARS-CoV-2 assay for CE Mark approval in Europe later this month, according …

What medtech’s top CEOs are saying about COVID-19

The COVID-19 pandemic is drying up sales for many large medical device companies, but there’s hope for a recovery later this year.

That’s the big message from medtech’s top CEOs as they issue financial predictions and engage in earnings calls with analysts.

Governments around the world are calling on medical device companies to make the supplies that health providers need to manage the virus: respirator masks, ventilators, infusion pumps, virus and antibody tests, and more.

At the same time, the same companies are taking a hit related to the devices and products used in elective procedures — and even procedures that people actually need — as hospitals focus on saving people with COVID-19.

It’s little wonder then that MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remains down about 10% from its pre-pandemic Feb. 19 high point. (It’s still in better shape than the Dow Jones Industrial Averag…

Dexcom completes sale of $1.05B in notes

Dexcom (NSDQ:DXCM) announced that it completed the sale of $1.05 billion aggregate principal amount of its convertible senior notes.

The San Diego-based continuous glucose monitoring system developer announced earlier this week that it was offering $850 million in notes with plans to offer note purchasers a 13-day option to buy up to an additional $150 million aggregate principal amount of notes.

A day later, the company increased the aggregate principal amount and granted a 13-day option to purchase up to an additional $157.5 million in notes, upsizing the total to the $1.05 billion it sold.

DexCom expects that the net proceeds will total approximately $1.03 billion, or $1.19 billion if the initial purchasers exercise their option to purchase the additional notes. The company used approximately $282.6 million of the proceeds to pay the cash consideration and issued more than 1.9million shares of its common stock to repurchase or exchange approximately $…

Balt wins IDE approval to start STEM trial

Balt announced that it received FDA investigation device exemption (IDE) for its trial for the treatment of chronic sub-dural hematoma.

The Squid trial for the embolization of the middle meningeal artery (STEM) is a prospective, randomized controlled trial for Balt’s Squid liquid embolic device as a minimally invasive treatment option for the neurological disease.

Irvine, Calif.-based Balt will investigate the safety and effectiveness of middle meningeal artery (MMA) embolization with the Squid device for managing CSDH in both surgical and non-surgical patients.

Co-primary investigator Dr. Adam Arthur of the Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center said in a news release that the study will help to understand how to treat a major reversible cause of dementia and disability in the elderly.

“The approval of the IDE for the STEM trial represents a significant milestone for Balt as this wil…

Researchers develop 3D VR blood flow to improve cardiovascular care

[Image from Duke University]

Duke University engineers are developing a fluid dynamics simulator that models blood flow in the full human arterial system at a subcellular resolution.

The biomedical engineers hope the simulator will give doctors guidance in treatment plans by simulating specific vasculatures of patients to predict how stent placements, conduit insertions and other geometric alterations to blood flow can affect surgical outcomes.

Duke University researchers developed the tool, called Harvey, by exploring various interfaces ranging from standard desktop displays to immersive virtual reality experiences. They found that futuristic interfaces could be the key to widespread adoption of the technology.

“Harvey currently requires knowledge of C coding and command-line interfaces, which really limits who can use the program,” Amanda Randles, assistant professor of biomedical sc…